Definition Compliance vs. Registration - What is the difference?

K

KHAN786

#1
Compliance vs. Registration - What is the difference? I.E WHAT IS MEANT BY U HAVE TO BE WORKING TOWARDS COMPLIANCE OR REGISTERATION
 
Elsmar Forum Sponsor
T

Tom Goetzinger

#2
Typically, "compliance" indicates that YOU say you meet the requiremens of the standard. "Registration" means that an approved third party registrar has audited you and certified that you meet the requirements of the standard.
 
Thread starter Similar threads Forum Replies Date
D Compliance to 21 CFR Part 11 Require Registration to FDA? Qualification and Validation (including 21 CFR Part 11) 9
Q FDA Establishment Registration - Does registration require compliance to the QSR? ISO 13485:2016 - Medical Device Quality Management Systems 8
optomist1 Informational Training IMDS - Management of Product Chemical Regulatory Compliance RoHS, REACH, ELV, IMDS and Restricted Substances 2
G ISO 14001 - 6.1.3 Compliance Obligations ISO 14001:2015 Specific Discussions 1
Ed Panek Compliance with Standards? When a standard is updated/revised CE Marking (Conformité Européene) / CB Scheme 3
K IEC 62304 compliance - Code reviews as part of verification strategy IEC 62304 - Medical Device Software Life Cycle Processes 5
N Which EN ISO 17664 version compliance to EU MDR? Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 3
N Audit non-compliance API Q1 - Use of External Documents 4.4.4 in Product Realization Oil and Gas Industry Standards and Regulations 5
C Compliance with ISO 17025 requirement 8.4.2 - Controls - Records recovery ISO 17025 related Discussions 4
J Management Representative and PRRC (Person Responsible for Regulatory Compliance) ISO 13485:2016 - Medical Device Quality Management Systems 4
N Audit non-compliance - API Spec Q1 9th Ed 5.6.1.2 b Oil and Gas Industry Standards and Regulations 10
J Interesting Discussion Compliance with regulations in exceptional circumstances EU Medical Device Regulations 5
L Wearables 21 CFR Part 11 compliance Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
V Preparing the IFU in compliance with MDR 745, Chapter III EU Medical Device Regulations 2
L AS9146 Implementation and Compliance AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
P MDR PRRC (person responsible for regulatory compliance) and personal liability EU Medical Device Regulations 2
R Foam mattresses used in hospitals - compliance with MDR requirements? EU Medical Device Regulations 6
E Machines in Europe not in compliance with the EC directive CE Marking (Conformité Européene) / CB Scheme 0
N EUDAMED postponement and compliance with Article 120 (3) MDR for Legacy Devices EU Medical Device Regulations 8
R Role of quality compliance in SAP Software Quality Assurance 2
E Part 11 Compliance, Excel living documents (i.e. document master list, equipment list, approved supplier list) Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 3
M MDR Legacy Medical Device Labeling compliance timeline EU Medical Device Regulations 3
D Required Checklist Showing Compliance to IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 11
D What is the best software used for the pharma compliance management? Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
T Rumours that class 1 NS, NM, NR devices will have a new deadline for MDR compliance EU Medical Device Regulations 3
M Informational From RAPS: Danish Regulators Seek to Help Smaller Companies With EU MDR Compliance Medical Device and FDA Regulations and Standards News 0
G ISO 9001 Legal Compliance and Legal Register Requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
Ed Panek Do Cloud services require 21 CFR Part 11 compliance? Qualification and Validation (including 21 CFR Part 11) 7
R Certificate of compliance to RoHS/REACH/WEEE - any such animal? REACH and RoHS Conversations 18
Sidney Vianna Interesting Discussion Legal compliance as part of ISO 45001 accredited certification. Major OSHA penalties in the USA. Occupational Health & Safety Management Standards 15
D Control chart applicable? Percentage of compliance with a standard Statistical Analysis Tools, Techniques and SPC 2
J Business Intelligence and 21 CFR Part 11 Compliance Qualification and Validation (including 21 CFR Part 11) 1
M Informational US FDA issued the first warning letter for UDI violations to help ensure compliance Medical Device and FDA Regulations and Standards News 0
D USFDA vs NRTL/IEC 17025 Differences - Compliance testing lab ISO 17025 related Discussions 0
D USFDA vs NRTL/IEC 17025 Differences - Compliance testing lab US Food and Drug Administration (FDA) 6
I CAP/CLIA Environment - Part 11 Compliance Qualification and Validation (including 21 CFR Part 11) 3
M Informational Medtech Europe guidance – Use of Symbols to Indicate Compliance with the MDR Medical Device and FDA Regulations and Standards News 5
lilybef Medical Devices & US TAA (Trade Agreement Act) Compliance - 2019 Hospitals, Clinics & other Health Care Providers 5
M How is Class I Medical Device Compliance Enforced? EU Medical Device Regulations 7
N Comprehensive Compliance Matrix for Internal Audit Checklist Other Medical Device Regulations World-Wide 1
K Is Compliance Testing of IEC 60601-2-63 mandatory for Europe - Dental X-Ray machine CE Marking (Conformité Européene) / CB Scheme 3
K IEC 60601-1-9 Compliance mendatory or Not - CT Scan machine CE Marking (Conformité Européene) / CB Scheme 8
L IEC 60601-1-11 IP22 Compliance - Ingress protection testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
P Relevance of Offsite backups process compliance and ISO 27001 certification. IEC 27001 - Information Security Management Systems (ISMS) 3
A System for Compliance Management (Medical Device) Qualification and Validation (including 21 CFR Part 11) 4
B ISO 9001:2015 vs ISO 13485:2016 for MDR Compliance EU Medical Device Regulations 4
E Compliance to standards (ISO 80369) but the ID is out of specification Other ISO and International Standards and European Regulations 0
L REACH Compliance - Small, family-owned contract manufacturer REACH and RoHS Conversations 16
C Person Responsible for Regulatory Compliance - The RA guy/girl Employment Act EU Medical Device Regulations 4
E Template of a Management Review Agenda or Report in compliance with ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 6

Similar threads

Top Bottom